Antibiotic Prophylaxis, Hepatic Surgery, Pancreatic Surgey
Conditions
Keywords
PK/PD target atttainment, piperacillin, surgical site infection
Brief summary
Hepatic and pancreatic surgeries are associated with a high risk of surgical site infections, particularly in patients with preoperative biliary drainage, which is frequently associated with bacterial colonization of bile. In this context, perioperative antibiotic prophylaxis is essential, and recent guidelines recommend the use of piperacillin/tazobactam in selected high-risk patients. However, piperacillin, like other β-lactam antibiotics, exhibits pharmacokinetic variability that may be exacerbated during major surgery due to factors such as fluid shifts, hypoalbuminemia, and changes in volume of distribution. These alterations may result in suboptimal antibiotic exposure during the perioperative period, potentially compromising prophylactic efficacy. Despite these concerns, standard dosing regimens remain unchanged across different types of major abdominal surgery, including hepatic and pancreatic procedures, which differ significantly in terms of duration, physiological impact, and intraoperative management. The PROPHTAZ study is a prospective, single-center observational pharmacokinetic study designed to evaluate whether standard perioperative administration of piperacillin/tazobactam achieves predefined pharmacokinetic/pharmacodynamic (PK/PD) targets in patients undergoing hepatic or pancreatic surgery. The primary objective is to determine the proportion of patients achieving adequate PK/PD exposure during surgery. Secondary objectives include describing perioperative plasma concentrations, assessing pharmacokinetic variability, identifying factors associated with target non-attainment, and comparing outcomes between surgical subgroups. This study aims to provide clinically relevant data to assess the adequacy of current prophylactic dosing strategies and to support potential optimization of antibiotic administration in high-risk surgical patients.
Interventions
None listed
Sponsors
Central Hospital, Nancy, France
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults \> or = to 18 years old * Scheduled for major hepatic or pancreatic surgery * Receiving piperacillin/tazobactam as perioperative antibiotic prophylaxis according to guidelines
Exclusion criteria
* decline to participate * Known allergy of beta-lactam
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK/PD target attainment of piperacillin | 4 hours after the administration of piperacillin | Proportion of patients achieving the predefined\* PK/PD target during the perioperative period \*estimated free concentration of piperacillin (80% of the total concentration) above the MIC of the isolated pathogen from bile samples throughout the surgical procedure (from incision to wound closure) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma piperacillin concentration | 4 hours after the administration of piperacillin | Total (measured) et free (estimated) concentration of piperacilline throughout at two timepoints: surgical incision and wound closure |
| Factors associated with target attainment | 4 hours after the administration of piperacillin | Analysis of clinical and biological covariates associated with pharmacokinetic variability and the achievement of pharmacodynamic targets |
Countries
France
Contacts
CONTACTEmmanuel NOVY, MD, PhD
Outcome results
None listed